510(k) K141848
- Device
- IOGYN SYSTEM
- Applicant
- IOGYN, INC.
- 510(k) number
- K141848
- Product code
- PGT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-08-29
- Date received
- 2014-07-09
- Regulation
- 884.1710
- Classification name
- Insufflator, Hysteroscopic, Fluid, Closed-loop Recirculation With Cutter-coagulator, Endoscopic, Bipolar
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICH CHRISTENSEN
- Address
- 20195 Stevens Creek Blvd. Suite 120 Cupertino CA US 95014 95014
FDA Registration Numbers#
- 3009327445
- 3011011193
- 3043236281
- 2183613
- 1649518
Source Documents#
Legacy Summary#
summary
FDA Review#
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